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Lateral Wedge Insole With Subtalar Strapping for Knee Osteoarthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01739296
First received: November 22, 2012
Last updated: November 30, 2012
Last verified: November 2012
History of Changes
  Purpose

This is a clinical study to evaluate the efficacy of a lateral wedge insole with subtalar strapping in knee osteoarthritis treatment.


Condition Intervention
Osteoarthritis
 Other: Neutral insole with subtalar strapping (sham)
Other: Lateral wedge insole with subtalar strapping

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Lateral Wedge Insole With Subtalar Strapping for Knee Osteoarthritis: a Randomized Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Symptoms [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Evaluation of patient's symptoms using WOMAC (western ontario and mcmaster universities osteoarthritis index), VAS (visual analogic scale of pain) and Lequesne questionaires


Secondary Outcome Measures:
  • Ankle pain [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Number of patients that reported ankle pain related to the use of the insole as a measure of tolerability


Enrollment: 58
Study Start Date: June 2011
Study Completion Date: July 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Wedge
Lateral wedge insole with subtalar strapping Use of lateral wedge insoles with subtalar strapping for 5 to 10 hours daily
 Other: Lateral wedge insole with subtalar strapping
Lateral wedge insole with subtalar strapping
Other Name: Wedge
Sham Comparator: Neutral
Neutral insole with subtalar strapping (sham) Use of neutral insoles with subtalar strapping for 5 to 10 hours daily
 Other: Neutral insole with subtalar strapping (sham)
Neutral insole with subtalar strapping (sham)
Other Name: Neutral

Detailed Description:

The objective of this study is to evaluate the efficacy of a lateral wedge insole with subtalar strapping in knee osteoarthritis treatment. Fifty-eight patients with knee osteoarthritis were randomized to use either a lateral wedge or a neutral insole. VAS, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Lequesne questionnaires were applied at baseline, and weeks two, eight, and 24.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Meet the American College of Rheumatology criteria for knee Osteoarthritis
  • Varus malalignment of the knee
  • Absence of previous fracture on the index knee
  • Absence of previous surgery on the index knee
  • Absence of Rheumatoid Arthritis
  • No Intra-articular injection on the index knee in the past 6 months
  • Receiving usual care for Osteoarthritis for at least 6 months
  • Be able to understand and agree with the informed consent

Exclusion Criteria:

  • Undergo surgery during the study
  • Undergo Intra-articular injection during the study
  • Develop articular infection of the index joint during the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01739296

Locations
Brazil
Instituto de Ortopedia e Traumatologia HC-FMUSP
São Paulo, SP, Brazil, 05410-000
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Gustavo C Campos, MD FMUSP
  More Information

Additional Information:
Brazilian Orthopaedics Association  This link exits the ClinicalTrials.gov site
Orthopaedics and Traumatology Institute website  This link exits the ClinicalTrials.gov site
University of São Paulo website  This link exits the ClinicalTrials.gov site
Brazilian Knee Surgery Association website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01739296     History of Changes
Other Study ID Numbers: 839/2011
Study First Received: November 22, 2012
Last Updated: November 30, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo General Hospital:
osteoarthritis
osteoarthritis, knee
foot orthoses
orthotic insoles

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 19, 2013